RecruitingNot ApplicableNCT06641271

Study to Investigate Vagus Nerve Stimulation Paired With Motor Task for Remyelination and Functional Recovery

Vagus Nerve Stimulation to Promote Remyelination in Multiple Sclerosis


Sponsor

University of Colorado, Denver

Enrollment

70 participants

Start Date

Jan 21, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if stimulating the vagus nerve in combination with a motor task in people with multiple sclerosis can improve motor function. The main questions it aims to answer are: * Is stimulating the vagus nerve safe and feasible after demyelinating episodes? * Does a paired motor task with vagus nerve stimulation improve motor function with someone who has multiple sclerosis? Researchers will compare active vagus nerve stimulation to a sham stimulation to see if the paired vagus nerve stimulation can improve motor control. Participants will: * Come in for study visits over a six month period. Study visits are three times weekly for the first month, then single follow up visits at two, three, and six months. * During study visits, participants will complete 30 minutes of the paired vagus nerve stimulation with a motor task, specifically the grooved peg test. * At various timepoints in the study, motor and disability tests will be administered to see if there are any changes in motor control for that participants. These tests include the timed 25 foot walk test, expanded disability scale, the upper extremity portion of the Fugl-Meyer Assessment, and the Multiple Sclerosis Impact Scale - 29.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether stimulating the vagus nerve (a nerve running from the brain to the body) through the ear, paired with specific motor exercises, can help repair nerve fiber damage and improve hand function in people with multiple sclerosis. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with multiple sclerosis for at least 30 days since your last relapse - You have difficulty with hand tasks (takes longer than average to complete a peg test) - You have some level of disability or reported hand weakness in your dominant hand **You may NOT be eligible if...** - You have primary progressive multiple sclerosis - You have a history of seizures or epilepsy - You have other brain or nervous system diseases - You have had an infection in the past 30 days - You have an implanted device like a pacemaker or cochlear implant - You have an ear infection or abnormal ear anatomy - You are pregnant or breastfeeding - You cannot walk 25 feet continuously Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEClosed Loop Trans-Auricular Vagus Nerve Stimulation System

A closed loop system that delivers stimulation to the vagus nerve via the ear non-invasively following a trigger event.

DEVICEPlacebo

A closed-loop vagus nerve stimulation device that can deliver sham stimulation to the ear to simulate stimulation of the vagus nerve.


Locations(1)

Clinical Translational Research Center at CU Anschutz

Aurora, Colorado, United States

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NCT06641271


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